Gastroenterology. 2016 Mar 2.
Infliximab reduces endoscopic, but not clinical, recurrence of Crohn's disease following ileocolonic resection.
Regueiro M, Feagan BG, Zou B, et al.

BACKGROUND & AIMS: Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs following resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence.
METHODS: We evaluated the efficacy of infliximab in preventing post-operative recurrence of CD in 297 patients at 104 sites worldwide, from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary endpoint was clinical recurrence a composite outcome consisting of a CD Activity Index score above 200 and a ≥70 point increase from baseline, and endoscopic recurrence (Rutgeerts score greater than or equal to i2, determined by a central reader), or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary endpoint.
RESULTS: A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval [CI], -1.3% to 15.5%; P=.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared to the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% CI, 18.6% to 40.2%; P<.001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores greater than or equal to i2 (22.4% vs 51.3%; ARR with infliximab, 28.9%; 95% CI, 18.4% to 39.4%; P<.001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports.
CONCLUSIONS: Infliximab is not superior to placebo in preventing clinical recurrence following CD-related resection. However, infliximab does reduce endoscopic recurrence.

Dig Dis Sci. 2016 Feb 26.
Long-term follow-up of patients treated with infliximab for ulcerative colitis: predictive factors of response-an observational study.
García-Bosch O, Aceituno M, Ordás I, et al.

AIM: To evaluate the early and long-term efficacy of infliximab in ulcerative colitis and to determine predictors of response and colectomy.
METHODS: This is an ambidirectional cohort study in a tertiary referral center including patients who started infliximab within 2005 and 2008 and monitored until 2014. Efficacy was evaluated by partial Mayo scores at weeks 2, 4, 8, 30, and 54. Long-term treatment maintenance with infliximab and colectomy requirements were recorded.
RESULTS: Fifty-three patients were included with a median follow-up of 69.5 months. Clinical remission at the time point assessments was 40.8, 47.2, 54.7, 54.7, and 49.1 %. At the time of maximal follow-up, the proportion of patients under infliximab maintenance was 24.5 %. A higher level of albumin (OR 1.4, CI 95 % 1.06-1.8; p = 0.017) was predictive of a higher remission rate at week 8. Concomitant immunomodulators beyond 6 months were predictive of infliximab's long-term maintenance (OR 15.8, CI 95 % 1.8-135.4; p = 0.012). Colectomy was required in 41.5 %. Factors associated with a higher rate of colectomy at week 54 were previous treatment with cyclosporine (OR 3.4, CI 95 % 1.2-9.7; p = 0.012), absence of response at week 8 (OR 10.3, CI 95 % 3.3-31.7; p < 0.001), and not receiving concomitant immunomodulators (OR 4.1, CI 95 % 1.8-9; p = 0.002). Colectomy rates within the first 54 weeks were closely dependent on the number of variables present: none (0 %), 1 (26.3 %), 2 (71.4 %), or 3 (100 %) of them (log rank <0.0001).

J Crohns Colitis. 2016 Feb 23.
Ulcerative colitis remission status after induction with mesalazine predicts maintenance outcomes: the MOMENTUM trial.
Rubin DT, Bradette M, Gabalec L, et al.

BACKGROUND AND AIMS: This study assessed the efficacy of maintenance treatment with multimatrix mesalazine following achievement of complete or partial remission after induction treatment with high-dose multimatrix mesalazine.
METHODS: In this phase 3b/4 open-label, multicenter, prospective, single-arm study, patients with mild-to-moderate ulcerative colitis were treated with multimatrix mesalazine 4.8 g/day once daily for 8 weeks (induction phase). At Week 8, those who achieved complete or partial remission based on predefined clinical and endoscopic criteria were eligible to receive 12 months of multimatrix mesalazine 2.4 g/day once daily maintenance therapy. The primary endpoint was the proportion of patients in complete remission at Month 12.
RESULTS: 717 patients received induction treatment; 25.9% and 39.3% of patients achieved complete and partial remission, respectively, at Week 8. A total of 461 patients entered the maintenance phase. The likelihood of remaining in/achieving complete remission at Month 12 was higher for patients who entered the maintenance phase in complete remission compared with those who began maintenance in partial remission (47.8% vs 26.0%; P <0.001). At Month 12, mucosal healing (endoscopy score ≤1) was demonstrated in 76.4% (139/182) and 63.5% (176/277) of those who were in complete and partial remission, respectively, at the end of induction.
CONCLUSION: Patients achieving complete remission prior to dose reduction were more likely to remain in remission at Month 12.

Dig Liver Dis. 2016 Jan 29.
Burden of disease and patient-reported outcomes in patients with moderate to severe ulcerative colitis in the last 12 months - Multicenter European cohort study.
Van Assche G, Peyrin-Biroulet L, Sturm A, et al.

BACKGROUND: Treatment of ulcerative colitis (UC) is aimed at maintaining corticosteroid-free remission and improving quality of life (QoL). AIM: Assess patients' perception of disease burden and unmet clinical needs in moderate/severe UC patients.
METHODS: Adults surgery-free conventionally treated patients with Mayo score ≥6 were enrolled in an observational, cross-sectional, retrospective study in 11 European countries. Disease control was defined as Mayo score ≤2 with no sub-score >1. No corticosteroid was used the previous two months. Unmet clinical needs were defined as: non-controlled disease, self-perception of 'moderate'/'severe' disease, and dissatisfaction with treatments. Disease burden on QoL and work productivity were assessed (EuroQol-5D-5L, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Work Productivity and Activity Impairment (WPAI) in UC questionnaire).
RESULTS: UC patients (n=253) with mean Mayo score at enrolment of 4.9, 44.3% of patients had Mayo score ≥6. Main treatment was 5-ASA (75%). Overall, 25% met the composite endpoint for unmet clinical needs. Mean (SD) questionnaire scores were: EQ-5D-5L-VAS, 71 (19.1), EQ-5D-5L utility, 0.77 (0.19), SIBDQ, 4.8 (1.3), and WPAI, 26% (32%).
CONCLUSIONS: Patients with moderate/severe UC in the last 12 months treated with conventional therapies felt that their disease was not controlled and 25% reported unmet clinical needs. QoL and work productivity were seriously impaired

Inflamm Bowel Dis. 2016 Feb 24.
Risk of incident cancer in inflammatory bowel disease patients starting anti-TNF therapy while having recent malignancy.
Poullenot F, Seksik P, Beaugerie L, et al.

BACKGROUND: Patients with inflammatory bowel disease (IBD) and history of malignancy within the last 5 years are usually contraindicated for receiving anti-tumor necrosis factor (anti-TNF) agents. The aim of this study is to assess survival without incident cancer in a cohort of IBD patients exposed to anti-TNF while having previous malignancy within past 5 years.
METHODS: Data from IBD patients with previous malignancy diagnosed within the last 5 years before starting an anti-TNF agent were collected through a Groupe d'Etude Thérapeutiques des Affections Inflammatoires du tube Digestif multicenter survey. Inclusion date corresponded to the first anti-TNF administration after cancer diagnosis.
RESULTS: Twenty centers identified 79 cases of IBD patients with previous malignancy diagnosed 17 months (median; range: 1-65) before inclusion. The most frequent cancer locations were breast (n = 17) and skin (n = 15). After a median follow-up of 21 (range: 1-119) months, 15 (19%) patients developed incident cancer (8 recurrent and 7 new cancers), including 5 basal-cell carcinomas. Survival without incident cancer was 96%, 86%, and 66% at 1, 2, and 5 years, respectively. Crude incidence rate of cancer was 84.5 (95% CI, 83.1-85.8) per 1000 patient-years.
CONCLUSIONS: In a population of refractory IBD patients with recent malignancy, anti-TNF could be used taking into account a mild risk of incident cancer. Pending prospective and larger studies, a case-by-case joint decision taken with the oncologist is recommended for managing these patients in daily practice.

Crohns Colitis. 2016 Mar 1.
Inflammatory bowel disease phenotype as risk factor for cancer in a prospective multicenter nested case-control IG-IBD study.
Biancone L, Armuzzi A, Scribano ML, et al.

BACKGROUND AND AIMS: Cancer risk in Inflammatory Bowel Disease (IBD) is still debated. In a prospective, multicenter, nested case-control study, we aimed to characterize incident cases of cancer in IBD. The role of immunomodulators versus clinical characteristics of IBD as risk factors for cancer was also investigated.
MATERIALS AND METHODS: From January 2012 to December 2014, each IBD patient with incident cancer was matched with 2 IBD patients without cancer for: IBD type, gender, age. Risk factors were assessed by multivariate regression analysis.
RESULTS: IBD patients considered were 44,619: 21,953 Crohn’s Disease (CD), 22,666 Ulcerative Colitis (UC). Cancer occurred in 174 patients: 99 CD (CD-K), 75 UC (UC-K). Controls included 198 CD (CD-C), 150 UC (UC-C). Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p=0.042). Cancers involved: digestive system (36.8%), skin (13.2%), urinary tract (12.1%), lung (8.6%), breast (8%), genital tract (6.9%), thyroid (4.6%), lymphoma (3.5%), others (6.3%). In CD, penetrating behavior and combined thiopurines and TNFα antagonists were risk factors for cancer overall (OR [95% CI]: 2.33 [1.01-5.47]; 1.97 [1.1-3.5]) and for extracolonic cancers (OR 3.9 [1.56-10.1]; 2.15 [1.17-4.1]). In UC, risk factors were: pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26-5.1]; 5.09 [1.73-17.1]); disease-related surgery for CRC (OR 3.6 [1.0-12]); extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15-5.9]; 2.6 [1.04-6.6]).
CONCLUSIONS: In a multicenter study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC.

Dig Dis Sci. 2016 Mar 12]
Long-term outcomes of infliximab treatment in 582 Korean patients with Crohn's disease: a hospital-based cohort study.
Park SH, Hwang SW, Kwak MS, et al.

BACKGROUND AND AIMS: To date, no large-scale studies have evaluated long-term outcomes of infliximab (IFX) treatment in Korean patients with Crohn's disease (CD). METHODS: We analyzed long-term clinical responses to IFX in 582 Korean CD patients who received scheduled IFX treatments at Asan Medical Center. Clinical responses were defined as maintaining IFX without major abdominal surgery (MAS) or dose intensification.
RESULTS: Between February 2002 and July 2015, a total of 11,990 IFX infusions were administered to 582 Korean patients with CD over a median period of 36 months. At the end of follow-up, 316 (54.3 %) were still receiving IFX without MAS (71 patients, 12.2 %) or dose intensification (86 patients, 14.8 %). IFX was stopped in 109 (18.7 %) patients because of a loss of response (48 patients, 8.2 %), adverse events (30 patients, 5.2 %), or patient preferences or problems with reimbursement (31 patients, 5.3 %). The cumulative survival for maintenance of IFX without MAS or dose intensification was 89.0, 75.9, 68.3, and 50.8 % at 1, 2, 3, and 5 years, respectively. Multivariate regression analysis identified older age at the initiation of IFX (≥40 years, P = 0.006) and a longer disease duration (≥3 years, P = 0.020) as independent positive predictors of a poorer response to IFX.
CONCLUSIONS: The long-term efficacy of IFX in a large, real-life cohort of Korean patients with CD appears to be similar to that in previously published Western studies. Our findings support the early use of IFX to obtain better clinical outcomes.

Curr Med Res Opin. 2016 Mar 30:1-9.
Comparison of real-world outcomes of adalimumab and infliximab for patients with ulcerative colitis in the United States.
Sandborn WJ, Sakuraba A, Wang A, et al.

OBJECTIVE: We compared the real-world effectiveness of initiating adalimumab and infliximab among patients in the US who were naïve to tumor necrosis factor (TNF) inhibitors.
METHODS: A retrospective chart review was conducted to evaluate the real-world effectiveness among adults with ulcerative colitis (UC) initiating adalimumab or infliximab. Charts of patients with UC were abstracted by treating physicians (randomly selected from a nationally representative panel) in April 2014. Patient eligibility criteria included: adalimumab or infliximab initiation on/after 1 October 2012; no prior anti-TNF therapy, history of Crohn's disease, or colectomy; and ≥6 months of follow-up. Information on clinical outcomes (partial Mayo score, remission rate, physician global assessment (PGA), stool frequency, and rectal bleeding) and treatment patterns (dose escalations, discontinuations, switches, and treatment augmentations) were retrospectively reported by treating physicians. Kaplan-Meier curves and multivariate Cox proportional hazards regression models were used to assess the time to clinical outcomes and treatment changes for each therapy.
RESULTS: Overall, 170 physicians participated, contributing data on 380 and 424 patients who initiated adalimumab and infliximab, respectively. Baseline clinical characteristics were similar between groups. Both adalimumab- and infliximab-treated patients showed substantial improvements from baseline to follow-up in effectiveness measures; results of these measures were similar between the adalimumab and infliximab cohorts. Time to remission (p = 0.5241), no rectal bleeding (p = 0.7648), normal stool count (p = 0.9941), and normal PGA (p = 0.7697) showed no significant differences between therapies in unadjusted and adjusted comparisons. Unadjusted and adjusted time to event analysis of discontinuation (p = 0.7151), dose escalation (p = 0.6310), treatment augmentation (p = 0.1209), and switching (p = 0.7975) showed no significant differences between the two cohorts.
LIMITATIONS: Retrospective, observational design.
CONCLUSIONS: Adalimumab and infliximab were similarly effective in the treatment of moderate-to-severe UC in the real-world clinical setting.

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